Norfloxacin

Norfloxacin – antimicrobic drug from group of ftorkhinolon.

Form of release and structure

Norfloxacin is produced in the form of tablets, film coated: yellow, biconvex, oblong with the rounded ends, on one party – risk; on cross section – two layers, an inside layer of pale yellow or white color (on 10 pieces in blister strip packagings from a polyvinyl chloride film and the varnished printing aluminum foil, on 1 or 2 packagings in a cardboard pack).

Is a part of 1 tablet:

• Active agent: norfloxacin – 200 or 400 mg;
• Auxiliary components (200/400 mg of active agent respectively): aerosil (colloid silicon dioxide) – 3,6/7,2 mg, magnesium stearate – 3,6/7,2 mg, microcrystallic cellulose – 120,4/240,8 mg, croscarmellose sodium – 10,8/21,6 mg, кросповидон – 21,6/43,2 mg;
• Cover (200/400 mg of active agent respectively): a gidroksipropilmetiltsellyuloz (gipromelloz) – 6,57/13,14 mg, polyethyleneglycol 6000 (a macrogoal 6000) – 2,2/4,4 mg, titanium dioxide – 2,2/4,4 mg, yellow quinolinic dye – 0,03/0,06 mg.

Indications to use

Norfloxacin is appointed for treatment of the infections caused by microorganisms, sensitive to effect of active agent, including prostatitis, uncomplicated gonorrhea, infections of urinary tract (except for the chronic complicated and acute pyelonephritis).

Contraindications

Absolute:

• Deficit glyukozo-6-fosfatdegidrogenazy;
• The rupture of a sinew and tendinitis connected with reception of ftorkhinolon (including anamnestic data);
• Children's age up to 18 years;
• Period of pregnancy and lactation;
• Hypersensitivity to drug components.

Relative (Norfloxacin is appointed with care in the presence of the following diseases / states):

• Epilepsy;
• Liver/renal failure;
• Convulsive syndrome;
• gravis myasthenia.

Route of administration and dosage

Norfloxacin is accepted inside.

The mode of dosing is defined by indications.

Treatment:

• Infections of urinary tract: 2 times a day on 400 mg, the average duration of a course – 7-10 days, uncomplicated cystitis – 3-7 days, persistent recurrent infections of urinary tract – up to 3 months;
• Acute bacterial gastroenteritis: 2 times a day on 400 mg, the average duration of a course – 5 days;
• Acute gonococcal urethritis, pharyngitis, proctitis, cervicitis: 800 mg once;
• Typhoid: 3 times a day on 400 mg, the average duration of a course – 2 weeks.

Prevention:

• Sepsis: 2 times a day on 400 mg;
• Bacterial gastroenteritis: on 400 mg a day;
• Diarrhea of travelers: on 400 mg a day (it is necessary to begin administration of drug in 1 day prior to departure, therapy is continued throughout the entire period of a way, but not longer by 3 weeks);
• Recurrence of infections of urinary tract: on 200 mg a day.

Use of the lowered daily doses (1/2 therapeutic doses 2 times a day or a full single dose once a day) is required to patients at clearance of creatinine lower than 20 ml a minute (or concentration of serumal creatinine more than 5 mg / 100 by ml), and also the patient who is on a hemodialysis.

Side effects

• Cardiovascular system: heart consciousness, myocardial infarction;
• Central nervous system: a sleep disorder, a headache, dizziness, a pricking in fingers of hands, alarm, drowsiness, sleeplessness, a depression;
• Urinary systems: renal colic;
• Alimentary system: diarrhea, nausea, an anus itch, anorexia, an abdominal pain, heartburn, pains in a rectum or an anus, dyspepsia, a lock, not properly executed chair, a meteorism, vomiting, dryness of a mucous membrane of an oral cavity, an ulceration of a mucous membrane of an oral cavity, bitter smack in a mouth;
• Hemopoietic system: eosinophilia, leukopenia, thrombocytopenia, neutropenia;
• Skeletal and motive device: bursitis, puffiness of feet and brushes;
• Sense bodys: illegibility of visual perception;
• Integuments: itch, erythema, rash, urticaria;
• Laboratory indicators: decrease in hemoglobin and a hematocrit, increase in activity of aspartate aminotransferase, alaninaminotranspherase, an alkaline phosphatase, lactate dehydrogenase, a proteinuria, a giperkreatininemiya, increase in concentration of urea in blood, a glucosuria;
• Others: allergic reactions, fever, hyperhidrosis, hypostases, adynamy, fever, dorsodynia and breasts, dysmenorrhea.

As a result of carrying out post-market researches the following disturbances were recorded:

• Central nervous system: peripheral neuropathy, spasms, a tremor, a myoclonia, a syndrome to Giyena-Barra, an ataxy, a hypesthesia, paresthesias, mental disturbances (including confusion of consciousness);
• Cardiovascular system: lengthening of an interval of QT, ventricular arrhythmia (including tachycardia like "pirouette");
• Skeletal and motive device: gravis myasthenia aggravation, rupture of a sinew, tendinitis, increase in activity of a kreatinfosfokinaza;
• Urinary system: renal failure, intersticial nephrite;
• Alimentary system: hepatitis, stomatitis, pseudomembranous colitis, cholestatic jaundice, pancreatitis, a liver failure (including with a lethal outcome);
• Hemopoietic system: hemolitic anemia, agranulocytosis;
• Sense bodys: diplopia, sonitus, decrease in hearing, dysgeusia;
• Integuments: toxic epidermal necrolysis, Stephens-Johnson's syndrome, exfoliative dermatitis, mnogoformny erythema, photosensitization;
• Allergic reactions: Quincke's disease, anaphylactoid reactions, asthma, vasculitis, arthralgia, arthritis, mialgiya;
• Others: hypoglycemia, lengthening of a prothrombin time, albuminuria, kandiduriya, cylindruria, crystalluria, dysphagy, hyperglycemia, hyperpotassemia, hypercholesterolemia, postural hypotension, gipertriglitseridemiya, hamaturia, liver necrosis, nystagmus, vagina candidiasis.

Special instructions

During therapy patients under control of a diuresis have to receive adequate amount of liquid.

During use of Norfloxacin the prothrombin ratio can increase (surgical interventions need to be carried out under control of a condition of system of a blood coagulation).

Administration of drug increases probability of development of a tendinitis and rupture of sinews. Treats risk factors: the chronic renal failure, transplantation of a kidney, lung or heart, age is more senior than 60 years, a combination therapy with glucocorticosteroids, the increased physical activity, damage of sinews in the anamnesis (including a pseudorheumatism). These disturbances can develop also in several months after end of a course. At emergence of the first signs of a tendinitis or rupture of a sinew it is necessary to interrupt administration of drug and to address the specialist.

During therapy it is necessary to avoid impact of a direct sunlight.

Norfloxacin can lower a threshold of convulsive readiness and lead to emergence of spasms. Also ftorkhinolona can stimulate the central nervous system, causing hallucinations, concern, a tremor, toxic psychoses, confusion of consciousness and to promote increase in intracranial pressure.

Norfloxacin can lead to development of the caused Clostridium difficile of pseudomembranous colitis. In these cases it is necessary to cancel drug and to appoint the corresponding therapy (use of metronidazole or Vancomycinum orally).

At treatment of syphilis Norfloxacin is not appointed (drug is not effective).

It is not necessary to exceed the recommended dosing mode as it can lead to formation of crystals of active agent in kidneys.

Norfloxacin can cause peripheral neuropathy (in the form of paresthesias, a hypesthesia, dizesteziya, muscular weakness). To avoid development of irreversible changes, at emergence of the first symptoms of a disease (a pricking, pain, weakness or numbness in extremities, disturbance of other types of sensitivity) therapy should be cancelled.

During control of vehicles and performance of potentially dangerous works demanding bystry psychomotor reactions and the increased concentration of attention it is necessary to be careful (in particular at the simultaneous use with ethanol).

Medicinal interaction

At combined use of Norfloxacin with some drugs there can be following effects:

• Theophylline: decrease in its clearance (decrease in its dose is required);
• Nitrofurans: decrease in their efficiency;
• Indirect anticoagulants, cyclosporine: increase in their concentration in blood serum;
• The drugs reducing a threshold of convulsive readiness (including nonsteroid antiinflammatory medicines): development of spasms;
• Antacids with the content of aluminum or magnesium hydroxide, and also the drugs containing сукральфат, ^Zn2+, Fe: decrease in absorption of norfloxacin (the break between their use has to make not less than 4 hours);
• CYP1A2 isoenzymes (including ропинирол, caffeine, clozapine, theophylline, такрин, тизанидин): increase in concentration of its substrates in blood;
• Probenetsid: decrease in excretion of norfloxacin;
• Glibenclamidum: development of a heavy hypoglycemia;
• Antacids, диданозин, сукральфат, polyvitamins with the content of zinc: decrease in absorption of norfloxacin (the break between their use has to make not less than 2 hours).

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 2 years.